Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim Status
Claims 1-10, 12 and 14-21 are pending. Claim 21 has been added. Claims 11 and 13 have been canceled. Claims 1, 7, 12, 15-16 and 20 have been amended. Claims 1-10, 12 and 14-21 are being examined in this application. In the response to the restriction requirement, Applicants elected the first topical composition comprising palmitoyl tripeptide-1, palmitoyl hexapeptide-12, and phosphatidylserine; the second topical composition comprising palmitoyl tripeptide-1, palmitoyl hexapeptide-12, hexapeptide-11, acetyl tetrapeptide-2, phosphatidylserine, lecithin, and propanediol; wherein the first topical composition is applied before and after the skin procedure or the surgical procedure; and the second topical composition is applied after the skin procedure or the surgical procedure.
Claim Rejections - 35 USC § 112
The rejection of claim 20 under 35 USC 112(b) is withdrawn in view of the amendments to the claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
This is a new rejection.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 is drawn to the method of claim 1, wherein the first topical composition is substantially non-aqueous.
The word “substantially” is unclear. A composition can be either aqueous or non-aqueous. In the instant case, one of ordinary skill would not understand whether the first composition can comprise any aqueous substance or not.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
This rejection is maintained.
Claims 7-9 and 20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 is drawn to the method of claim 1, wherein the one or more inflammatory or regenerative genes encodes………or a fragment or variant thereof. Fragments or variants are not encompassed by claim 1. Therefore, claim 7 fails to include all the limitations of claim 1. Furthermore, what is encoded by the one or more inflammatory or regenerative genes is inherent to the instantly claimed compositions. Similarly, claims 8-9 fail to further limit the subject matter of claim 1. With respect to claim 20, anything that the method accelerates is inherent to the instantly claimed compositions. Therefore, claim 20 fails to further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments
Applicant’s arguments filed on 2/9/2026 have been fully considered but they are not persuasive.
Applicant argues that “[A] dependent claim complies with 35 U.S.C. §112(d) when it includes all limitations of the claim from which it depends and then specifies a further limitation. See MPEP § 608.01(n). Each of claims 7-9 and 20 add further limitations to claim 1, which are not inherent to claim 1. Claim 1 recites that the method "modulates an expression level of one or more inflammatory or regenerative genes," without specifying which and how many genes are modulated. For the inflammatory or regenerative genes recited in claims 7-9 to be inherent, the method of claim 1 must necessarily modulate all inflammatory or regenerative genes, for which the Office Action does not provide evidence. Rather, modulation of the specific genes listed in claims 7-9 is not inherent, and by specifying the genes the claims further limit claim 1. Similarly, the specific functional outcomes recited in claim 20 are not inherent to the method for improving wound healing of claim 1, nor does the Office Action point to any evidence showing such inherency. Wound healing may be improved by mechanisms not recited in claim 20”.
Applicant’s arguments are not persuasive because the method claimed requires only the administration of the first and second compositions.
The decision In re Omeprazole Patent Litigation, 483 F.3d 1364, 1373, 82 USPQ2d 1643, 1650 (Fed. Cir. 2007) is controlling in this case.
“[T]he court noted that although the inventors may not have recognized that a characteristic of the ingredients in the prior art method resulted in an in situ formation of a separating layer, the in situ formation was nevertheless inherent. "The record shows formation of the in situ separating layer in the prior art even though that process was not recognized at the time. The new realization alone does not render that necessary [sic] prior art patentable."”.
Therefore, since the compositions applied in instant claims 7-9 and 20 are the exact compositions of claim 1, and since no further steps are claimed, the limitations of claims 7-9 and 20 are merely the result of the administration of said compositions.
For the reasons stated above the rejection is maintained.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This rejection has been modified.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Garruto et al. (US 2019/0038539).
With respect to claims 1-6 and 10-14, Garruto et al. teach formulations comprising a combination of two or more peptides are provided for promoting healthy skin, skin regeneration, and enhanced wound healing, e.g., in patients subject to a skin procedure such as a laser treatment, a chemical peel, dermabrasion, microneedling, and other such procedures (para [0131]; claim 1), wherein the peptide is selected from tripeptide-1, tetrapeptide-2, hexapeptide-12, or hexapeptide-11 (para [0133]), and wherein the formulation is configured to support the skin before, during and after cosmetic procedures (para [0195]).
Garruto et al. also teach that tripeptide-1 is present at 1-10 ppm (claim 2-3; paras [0006]-[0007]), hexapeptide-11 is present at about 0.005% to about 0.02% by weight (claim 6; paras [0006]-[0007]), and hexapeptide-12 is present at 0.5-10 ppm (claim 7; paras [0006]-[0007]).
Garruto et al. also teach that the topical composition is administered for at least one week, 2 weeks, 4 weeks, 8 weeks, or 12 weeks (para [0007]).
Garruto et al. do not teach applying a first and a second topical composition.
The MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to administer a first topical composition and a second topical composition, and to find the optimum time of administration, by normal optimization procedures known in the pharmaceutical art.
The skilled artisan would have had a reasonable expectation of success because Garruto et al. teach that the formulations can comprise tripeptide-1, tetrapeptide-2, hexapeptide-12 and hexapeptide-11.
With respect to the claimed amount sufficient to modulate an expression level of one or more inflammatory or regenerative genes, the instant specification does NOT teach said amount.
Furthermore, Garruto et al. teach that the amount of the various peptides of the formulation can be adjusted (para [0131]).
Thus, one of ordinary skill in the art would have arrived at the instantly claimed amount of the claimed topical composition by normal optimization procedures known in the pharmaceutical art (see MPEP 2144).
With respect to claims 7-9, as discussed above, these claims do not further limit the subject matter of claim 1, thus, they are obvious over Garruto et al. Furthermore, Garruto et al. teach that GHK (i.e. tripeptide-1) induces angiogenesis or new blood vessel formation by increasing the production of growth factor proteins necessary for angiogenesis such as basic fibroblast growth factor (BFGF) and vascular endothelial growth factor (VEGF).
With respect to claims 15-17, Garruto et al. teach that the formulation further comprises phosphatidylserine and oleuropein (paras [0150]-[0154]).
With respect to claim 18, Garruto et al. teach that the topical composition further comprises ceramide NP, Tremella fuciformis extract, niacinamide, hydrogenated lecithin, C12-16 alcohols, palmitic acid, avocado extract, shea butter, bentonite, phytoene/phytofluene, hydroxymethoxyphenyl decanone, polyholosides, Plantago lanceolata, dill extract, phosphatidylserine, oleuropein, hydrolyzed Candida saitoana extract, Centella asiatica, propanediol, lecithin, Euglena gracilis extract, aqua, caffeine, Glaucium flavum leaf extract, or combinations thereof (para [0006]).
With respect to claim 19, Garruto et al. teach that the skin procedure comprises a laser treatment (para [0131]).
With respect to claim 20, as discussed above, this claim does not further limit the subject matter of claim 1, thus it is obvious over Garruto et al.
With respect to claim 21, Garruto et al. do NOT teach that the topical composition is aqueous.
Response to Arguments
Applicant’s arguments filed on 2/9/2026 have been fully considered but they are not persuasive.
Applicant argues that “[G]arruto does not teach or suggest applying two different topical compositions in a temporally ordered, pre-procedure/post-procedure regimen”.
Applicant also argues that “[G]arruto does not recognize the claim features, including the multi-stage dosing regimen in which different compositions are applied, let alone that application of one or both of the compositions modulates expression of one or more inflammatory or regenerative genes. Accordingly, optimizing the treatment parameters of Garruto would not have resulted in the claimed method”.
Applicant further argues that “[a]s explained in the specification at paragraph [0269], the claimed dual formulation method achieves performance not contemplated by the prior art, including Garruto: [A]n accelerated healing response that involves the clearance of 'waste' products and the induction of anti-inflammatory genes. Furthermore, this topical treatment stimulates ECM remodeling, which ultimately improves the long-term results of the healing process, leading to less induration. This effect is demonstrated at least in Examples 2 and 3 of the application. The prior art does not teach or suggest that stimulation of ECM remodeling reduces induration or that its formulations induce anti-inflammatory genes”.
Applicant’s arguments are not persuasive.
Garruto et al. teach that the method modulates the expression of several inflammatory and regenerative genes (Tables 16A-B). One of ordinary skill in the art would have reasonably expected the expression of other inflammatory and regenerative genes to be modulated.
Furthermore, since the Office does not have the facilities for examining and comparing applicants’ method with the method of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed method and the method of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Moreover, the MPEP 716.02(e) states that “[e]vidence of unexpected results must compare the claimed invention with the closest prior art”.
In the instant case, to rebut a prima facie case of obviousness, Applicant should compare the instantly claimed method with the method of Garruto et al.
For the reasons stated above the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658